非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.123624436389361333614836317362460.31
211.153687936535367070.67
单位质量响应值RSD%判断
3259.533292.110.71数据可信
供试品溶液-2批-多替诺雷-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120345-2034555.72457.543.8655.7257.543.86
221603-2160359.17059.17
321815-2181559.75059.75
421805-2180559.72359.72
520314-2031455.63955.64
620163-2016355.22655.23
10min132591-3259189.26588.950.2789.3689.050.27
232505-3250589.03089.13
332476-3247688.95089.05
432411-3241188.77288.87
532352-3235288.61188.70
632522-3252289.07689.17
15min134443-3444394.33894.370.4694.5894.620.46
234660-3466094.93295.18
334585-3458594.72794.97
434222-3422293.73293.98
534348-3434894.07894.32
634479-3447994.43694.68
20min135072-3507296.06196.060.2696.4696.460.26
235100-3510096.13796.54
335183-3518396.36596.77
435039-3503995.97096.37
534914-3491495.62896.03
635117-3511796.18496.58
30min135553-3555397.37897.260.5897.9497.820.58
235249-3524996.54597.11
335783-3578398.00898.57
435284-3528496.64197.20
535629-3562997.58698.14
635555-3555597.38497.94
45min135929-3592998.40898.130.2899.1398.850.28
235813-3581398.09098.82
335942-3594298.44499.17
435717-3571797.82798.55
535721-3572197.83898.56
635835-3583598.15098.87
60min135871-3587198.24998.510.6899.1399.390.67
235907-3590798.34899.24
336088-3608898.84399.74
435578-3557897.44798.33
536299-3629999.421100.30
636047-3604798.73199.62
90min136217-3621799.19798.800.51100.2599.850.51
236001-3600198.60599.66
336129-3612998.956100.01
435743-3574397.89898.95
536245-3624599.273100.32
636095-3609598.86399.91
120min136033-3603398.69398.850.4599.91100.070.44
236211-3621199.180100.40
336185-3618599.109100.33
435932-3593298.41699.63
536285-3628599.383100.60
635895-3589598.31599.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.381.380.30
2-0.0001.38
3-0.0001.39
4-0.0001.38
5-0.0001.38
6-0.0001.38
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.082678532664292671502669682668992670600.20
211.102710172715902713040.15
单位质量响应值RSD%判断
24102.8924441.800.99数据可信
供试品溶液-2批-非布司他-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1174844-17484464.76967.637.3364.7767.637.33
2185633-18563368.76668.77
3182251-18225167.51367.51
4207550-20755076.88576.88
5172747-17274763.99263.99
6172367-17236763.85263.85
10min1253959-25395994.07693.541.1794.1893.651.17
2253790-25379094.01494.13
3246511-24651191.31791.43
4253513-25351393.91194.04
5253333-25333393.84593.95
6253953-25395394.07494.18
15min1263653-26365397.66897.270.6797.9397.540.67
2263995-26399597.79498.07
3259149-25914995.99996.26
4262705-26270597.31697.60
5263057-26305797.44797.71
6262899-26289997.38897.65
20min1265701-26570198.42698.000.9298.8598.430.91
2265921-26592198.50898.94
3259693-25969396.20196.63
4265330-26533098.28998.74
5264830-26483098.10498.53
6265837-26583798.47798.90
30min1268250-26825099.37098.511.3099.9699.111.29
2268121-26812199.32399.92
3259192-25919296.01596.60
4265609-26560998.39299.00
5267473-26747399.08399.67
6266972-26697298.89799.49
45min1269069-26906999.67498.651.46100.4399.411.45
2268911-26891199.615100.38
3258911-25891195.91196.66
4265288-26528898.27399.05
5267871-26787199.23099.98
6267745-26774599.18399.94
60min1268300-26830099.38998.721.27100.3199.641.26
2268410-26841099.430100.36
3260070-26007096.34097.25
4265425-26542598.32499.26
5268468-26846899.451100.37
6268299-26829999.389100.31
90min1267610-26761099.13398.181.38100.2299.271.37
2266504-26650498.72499.82
3257962-25796295.55996.62
4264623-26462398.02799.13
5266051-26605198.55699.64
6267512-26751299.097100.18
120min1266873-26687398.86098.301.08100.1199.551.08
2267471-26747199.082100.34
3260044-26004496.33197.56
4264239-26423997.88599.15
5266278-26627898.64099.89
6267265-26726599.006100.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.421.421.07
2-0.0001.43
3-0.0001.39
4-0.0001.43
5-0.0001.41
6-0.0001.42
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.127200272208717337182271695718920.30
211.157275172681727160.07
单位质量响应值RSD%判断
6465.116521.610.62数据可信
供试品溶液-1批-多替诺雷-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138687-3868753.45652.5014.7453.4652.5014.73
240960-4096056.59756.60
340298-4029855.68255.68
441832-4183257.80257.80
539379-3937954.41254.41
626796-2679637.02637.03
10min161112-6111284.44286.452.8484.5386.542.85
263474-6347487.70687.80
363403-6340387.60887.70
464052-6405288.50588.60
563724-6372488.05188.14
659637-5963782.40482.47
15min166564-6656491.97693.661.1692.2193.891.16
267773-6777393.64693.89
367475-6747593.23493.47
468662-6866294.87495.12
568613-6861394.80795.04
667601-6760193.40893.61
20min168095-6809594.09195.831.0294.4796.221.02
268989-6898995.32695.72
369912-6991296.60297.00
469850-6985096.51696.92
569778-6977896.41696.81
669494-6949496.02496.38
30min169213-6921395.63696.980.9496.1897.520.93
269831-6983196.49097.05
369809-6980996.45997.01
470712-7071297.70798.27
570749-7074997.75898.31
670780-7078097.80198.32
45min169864-6986496.53597.961.0597.2398.671.05
270766-7076697.78298.50
370222-7022297.03097.75
471728-7172899.11199.84
571458-7145898.73899.46
671336-7133698.56999.25
60min170676-7067697.65798.490.8098.5299.360.79
271030-7103098.14699.03
370674-7067497.65598.53
471753-7175399.145100.04
571516-7151698.81899.70
672003-7200399.491100.33
90min170533-7053397.46098.931.0498.4899.961.04
272272-7227299.863100.91
370848-7084897.89598.94
471936-7193699.398100.45
571669-7166999.029100.08
672305-7230599.908100.92
120min170533-7053397.46098.770.9398.6599.970.92
271121-7112198.27299.48
371108-7110898.25499.46
472173-7217399.726100.95
571802-7180299.213100.43
672140-7214099.680100.85
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.351.371.37
2-0.0001.37
3-0.0001.37
4-0.0001.39
5-0.0001.38
6-0.0001.34
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.085348885340695333385340985337955340380.11
211.105404645405155404900.01
单位质量响应值RSD%判断
48198.3848692.790.73数据可信
供试品溶液-1批-非布司他-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1345465-34546564.11662.5315.0364.1262.5415.04
2364496-36449667.64867.65
3356046-35604666.08066.08
4370573-37057368.77668.78
5349777-34977764.91764.92
6235309-23530943.67243.67
10min1488157-48815790.59992.302.2090.7192.412.21
2501569-50156993.08893.20
3499197-49919792.64892.76
4509686-50968694.59594.71
5504838-50483893.69593.80
6480536-48053689.18589.26
15min1514306-51430695.45296.770.9795.7197.020.97
2520100-52010096.52896.80
3519757-51975796.46496.73
4528498-52849898.08698.36
5525713-52571397.56997.83
6519912-51991296.49396.71
20min1521646-52164696.81597.840.8197.2398.260.81
2525614-52561497.55197.98
3523676-52367697.19197.62
4532537-53253798.83699.27
5531046-53104698.55998.99
6528387-52838798.06698.45
30min1527769-52776997.95198.630.7298.5399.220.72
2528152-52815298.02298.61
3528194-52819498.03098.62
4536153-53615399.507100.11
5534822-53482299.26099.85
6533573-53357399.02899.57
45min1528135-52813598.01998.830.8598.7699.580.85
2529085-52908598.19598.95
3529769-52976998.32299.07
4540224-540224100.263101.03
5534459-53445999.19399.95
6533308-53330898.97999.69
60min1529341-52934198.24398.780.7299.1599.690.71
2528576-52857698.10199.02
3528901-52890198.16199.08
4537172-53717299.696100.63
5533470-53347099.00999.93
6535991-53599199.477100.35
90min1528863-52886398.15498.820.6999.2299.900.68
2537043-53704399.672100.75
3527693-52769397.93799.02
4535138-53513899.319100.42
5531938-53193898.72599.81
6534042-53404299.115100.16
120min1528353-52835398.05998.430.5999.2999.670.59
2526531-52653197.72198.97
3527996-52799697.99399.23
4534319-53431999.167100.43
5532851-53285198.894100.15
6532004-53200498.73799.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.401.401.48
2-0.0001.41
3-0.0001.40
4-0.0001.43
5-0.0001.42
6-0.0001.37
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.123719037259371153711436826371010.45
211.153703137109370700.15
单位质量响应值RSD%判断
3336.423324.660.25数据可信
供试品溶液-2批-多替诺雷-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16563-656317.68016.917.9617.6816.917.97
26848-684818.44818.45
36380-638017.18717.19
45683-568315.30915.31
56543-654317.62617.63
65640-564015.19415.19
10min113104-1310435.30135.563.1135.3335.583.11
213609-1360936.66136.69
313502-1350236.37336.40
412582-1258233.89533.92
513505-1350536.38136.41
612891-1289134.72734.75
15min116376-1637644.11545.031.9944.2045.112.00
217019-1701945.84745.94
317138-1713846.16846.26
416401-1640144.18344.26
516854-1685445.40345.49
616500-1650044.44944.53
20min118531-1853149.92150.991.5050.0851.151.50
219113-1911351.48851.66
319233-1923351.81251.98
418736-1873650.47350.63
519163-1916351.62351.79
618783-1878350.59950.76
30min121176-2117657.04658.381.3757.2958.631.38
221852-2185258.86759.12
322038-2203859.36859.62
421534-2153458.01058.25
521766-2176658.63558.89
621660-2166058.35058.59
45min123577-2357763.51465.131.2663.8565.481.26
224399-2439965.72866.08
324358-2435865.61865.97
424271-2427165.38465.72
524272-2427265.38665.74
624191-2419165.16865.51
60min124964-2496467.25069.311.5767.7069.761.57
225720-2572069.28769.75
326079-2607970.25470.71
425798-2579869.49769.94
526048-2604870.17170.63
625764-2576469.40569.85
90min125929-2592969.85073.882.6970.4174.452.67
227707-2770774.64075.22
327785-2778574.85075.43
427793-2779374.87175.43
527730-2773074.70275.28
627604-2760474.36274.93
120min128051-2805175.56677.641.3876.2478.341.38
228862-2886277.75178.45
329148-2914878.52279.22
428852-2885277.72478.41
528927-2892777.92678.63
629092-2909278.37179.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限128403-2840376.51578.891.5377.3279.711.52
229250-2925078.79679.63
329533-2953379.55980.39
429510-2951079.49780.31
529441-2944179.31180.14
629572-2957279.66480.48
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.082776372771322762402755532737062760540.56
211.102779042783142781090.11
单位质量响应值RSD%判断
24914.6225054.860.40数据可信
供试品溶液-2批-非布司他-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137173-3717313.37712.618.5013.3812.608.52
238716-3871613.93213.93
334962-3496212.58212.58
431851-3185111.46211.46
536255-3625513.04713.05
631220-3122011.23511.23
10min163300-6330022.77922.642.6222.8022.662.62
264481-6448123.20423.23
364420-6442023.18223.20
460294-6029421.69821.72
563374-6337422.80622.83
661666-6166622.19122.21
15min174240-7424026.71626.931.8026.7826.991.81
276736-7673627.61427.68
375863-7586327.30027.36
473372-7337226.40426.46
575230-7523027.07227.13
673521-7352126.45726.51
20min179849-7984928.73528.274.0928.8428.384.06
282051-8205129.52729.63
377909-7790928.03728.14
479635-7963528.65828.76
572614-7261426.13126.24
679331-7933128.54828.65
30min186669-8666931.18931.131.8931.3431.291.88
287611-8761131.52831.69
383320-8332029.98430.14
487056-8705631.32831.48
587767-8776731.58431.73
686668-8666831.18931.34
45min181746-8174629.41731.614.9129.6231.824.88
291748-9174833.01733.23
392893-9289333.42933.63
484058-8405830.24930.45
588268-8826831.76431.97
688351-8835131.79431.99
60min195463-9546334.35433.093.7334.6133.353.70
290494-9049432.56532.83
392245-9224533.19633.45
486105-8610530.98631.24
595083-9508334.21734.47
692333-9233333.22733.48
90min196068-9606834.57135.4110.0634.8835.729.96
298822-9882235.56235.88
392609-9260933.32733.64
4117331-11733142.22342.52
588963-8896332.01432.33
696649-9664934.78035.09
120min1100084-10008436.01634.778.7736.3935.148.68
2100510-10051036.17036.55
398846-9884635.57135.94
479422-7942228.58128.95
5101227-10122736.42836.79
699708-9970835.88136.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限199659-9965935.86435.624.0036.2936.043.96
2100782-10078236.26836.71
3101210-10121036.42236.85
4100322-10032236.10236.52
5100903-10090336.31136.74
690973-9097332.73833.16
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